Coronary Artery DiseaseNCT06313008
Empagliflozin Versus Vildagliptin in CAD Patients With T2DM
A study testing Empagliflozin 10 MG and Vildagliptin 50 MG in people with Coronary Artery Disease and Type 2 Diabetes, run by Damanhour University at 1 site in Egypt.
Trial summary
We compared the cardioprotective effects of empagliflozin, an SGLT2 inhibitor, with those of vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, focusing on various inflammatory biomarkers lipid profile, and cardiac function, in patients with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Type 2 Diabetes
- What is being tested?
- Empagliflozin 10 MG and Vildagliptin 50 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2023to 10 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T2DM patients with chronic stable angina.
- patients with glycated hemoglobin (HbA1c) levels of 6.0-10.0%.
- patients aged 20-80 years.
- patients with a body mass index of ≥ 22 kg/m2.
- patients who provided written informed consent.
Who cannot join
- patients with type 1 diabetes mellitus or secondary diabetes mellitus.
- patients with renal dysfunction (estimated glomerular filtration rate < 45 mL/min/1.73 m2).
- patients with left ventricular ejection fraction (LVEF) < 30%.
- patients with untreated cancer.
- patients with hepatic cirrhosis.
- patients with liver failure that was virus-, autoimmune- or drug-induced.
Show all 10Show fewer
- patients with alcoholism.
- pregnant or breastfeeding patients, or those planning to become pregnant during the course of the study.
- patients allergic to empagliflozin or vildagliptin.
- patients with anemia (hemoglobin < 12 g/dL).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study Comparing Effects of Empagliflozin Versus Vildagliptin on Inflammatory Biomarkers, and Atrial Function in Coronary Artery Disease Patients With Type 2 Diabetes: EMBA-VILDA-Response Trial.
We compared the cardioprotective effects of empagliflozin, an SGLT2 inhibitor, with those of vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, focusing on various inflammatory biomarkers lipid profile, and cardiac function, in patients with type 2 diabetes mellitus (T2DM).
Read the detailed description
This was a prospective, randomized, double-dummy, parallel-group trial that enrolled 120 patients with T2DM. The patients were randomized 1: 1 for 6 months administration of empagliflozin or vildagliptin. by using consecutive ascending randomization numbers in the treatment blocks allocated to each study site. The randomization was stratified by the presence or absence of statin and oral antidiabetic therapy. The randomization list was produced using an automated random number generator.
Clinical parameters, assessment of atrial myocardial function, LVEF%, LA diameter, glycemic and lipid profile, adiponectin, high-sensitivity C-reactive protein, and Sortilin levels will be determined at baseline and after the 6 months of treatment period.
Patient compliance was evaluated by the counting of pills by a physician at selected time-points. In addition, patients were provided with individual diary cards to record administration of the study medication on a daily basis. These cards were checked regularly by site staff.
The study will be approved by the local ethics committee and was conducted in accordance with the Declaration of Helsinki and its amendments. All included patients provided written informed consent.
- Conditions
- Coronary Artery Disease, Type 2 Diabetes
- Being tested
- Empagliflozin 10 MG, Vildagliptin 50 MG
- Keywords
- CAD., T2DM., LVEF%., Sortilin., Empaglilozin., Vildagliptin.
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Also called Empa
eligible subjects were randomly and equally assigned to the empagliflozin add-on group (empagliflozin 10 mg/ day).
Vildagliptin 50 MGDrug
Also called Vilda
eligible subjects were randomly and equally assigned to vildagliptin add-on group (vildagliptin 50 mg/day as the initial dose).
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | Eligible subjects were randomly and equally assigned to the empagliflozin add-on group (empagliflozin 10 mg/ day). Receives: Drug: Empagliflozin 10 MG |
| Vildagliptin | Experimental | 60 patients recieved vildagliptin as add-on group (vildagliptin 50 mg/day as the initial dose). Receives: Drug: Vildagliptin 50 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
LVEF %
echocardiographic measurements
Measured: 6 months
Sortilin (ng/ml)
Serum Biomarkers
Measured: 6 months
LDL (mg/dl)
Lipid profile
Measured: 6 months
Secondary outcomes (3)
hsCRP (mg/L)
Serum Biomarkers
Measured: 6 months
HbA1c %
Glycemic control
Measured: 6 months
FBG (mg/dl)
Serum level
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start10 Aug 2023
- Primary completion30 Sep 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a prospective, randomized, double-dummy, blinded-endpoint, parallel-group trial that enrolled 120 CAD patients with T2DM. The patients were randomized 1: 1 for 6 months administration of empagliflozin or vildagliptin.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Lamiaa Khedr, Prof., Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313008
- Sponsor's protocol ID
- EMBA-VILDA-Response trial.
- Status last verified
- Nov 2024
- First submitted
- 9 Mar 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tanaka A, Shimabukuro M, Okada Y, Taguchi I, Yamaoka-Tojo M, Tomiyama H, Teragawa H, Sugiyama S, Yoshida H, Sato Y, Kawaguchi A, Ikehara Y, Machii N, Maruhashi T, Shima KR, Takamura T, Matsuzawa Y, Kimura K, Sakuma M, Oyama JI, Inoue T, Higashi Y, Ueda S, Node K; EMBLEM Trial Investigators. Rationale and design of a multicenter placebo-controlled double-blind randomized trial to evaluate the effect of empagliflozin on endothelial function: the EMBLEM trial. Cardiovasc Diabetol. 2017 Apr 12;16(1):48. doi: 10.1186/s12933-017-0532-8.
PubMed 28403850Shimizu W, Kubota Y, Hoshika Y, Mozawa K, Tara S, Tokita Y, Yodogawa K, Iwasaki YK, Yamamoto T, Takano H, Tsukada Y, Asai K, Miyamoto M, Miyauchi Y, Kodani E, Ishikawa M, Maruyama M, Ogano M, Tanabe J; EMBODY trial investigators. Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trial. Cardiovasc Diabetol. 2020 Sep 25;19(1):148. doi: 10.1186/s12933-020-01127-z.
PubMed 32977831Schernthaner G, Schernthaner-Reiter MH, Schernthaner GH. EMPA-REG and Other Cardiovascular Outcome Trials of Glucose-lowering Agents: Implications for Future Treatment Strategies in Type 2 Diabetes Mellitus. Clin Ther. 2016 Jun;38(6):1288-1298. doi: 10.1016/j.clinthera.2016.04.037. Epub 2016 May 19.
PubMed 27210264Naing S, Poliyedath A, Khandelwal S, Sigala T. Impact of EMPA-REG OUTCOME(R) on the management of type 2 diabetes mellitus: a review for primary care physicians. Postgrad Med. 2016 Nov;128(8):822-827. doi: 10.1080/00325481.2016.1245093. Epub 2016 Oct 25.
PubMed 27701934
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Comparing Effects of Empagliflozin Versus Vildagliptin on Inflammatory Biomarkers, and Atrial Function in Coronary Artery Disease Patients With Type 2 Diabetes: EMBA-VILDA-Response Trial.
- ClinicalTrials.gov ID
- NCT06313008
- Acronym / sponsor ID
- EMBA-VILDA-Response trial.
- Conditions
- Coronary Artery Disease, Type 2 Diabetes
- Keywords
- CAD., T2DM., LVEF%., Sortilin., Empaglilozin., Vildagliptin.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We compared the cardioprotective effects of empagliflozin, an SGLT2 inhibitor, with those of vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, focusing on various inflammatory biomarkers lipid profile, and cardiac function, in patients with type 2 diabetes mellitus (T2DM).
Detailed description
This was a prospective, randomized, double-dummy, parallel-group trial that enrolled 120 patients with T2DM. The patients were randomized 1: 1 for 6 months administration of empagliflozin or vildagliptin. by using consecutive ascending randomization numbers in the treatment blocks allocated to each study site. The randomization was stratified by the presence or absence of statin and oral antidiabetic therapy. The randomization list was produced using an automated random number generator.
Clinical parameters, assessment of atrial myocardial function, LVEF%, LA diameter, glycemic and lipid profile, adiponectin, high-sensitivity C-reactive protein, and Sortilin levels will be determined at baseline and after the 6 months of treatment period.
Patient compliance was evaluated by the counting of pills by a physician at selected time-points. In addition, patients were provided with individual diary cards to record administration of the study medication on a daily basis. These cards were checked regularly by site staff.
The study will be approved by the local ethics committee and was conducted in accordance with the Declaration of Helsinki and its amendments. All included patients provided written informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This was a prospective, randomized, double-dummy, blinded-endpoint, parallel-group trial that enrolled 120 CAD patients with T2DM. The patients were randomized 1: 1 for 6 months administration of empagliflozin or vildagliptin.
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: Empagliflozin 10 MGEligible subjects were randomly and equally assigned to the empagliflozin add-on group (empagliflozin 10 mg/ day). |
| Vildagliptin | Experimental | Drug: Vildagliptin 50 MG60 patients recieved vildagliptin as add-on group (vildagliptin 50 mg/day as the initial dose). |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- T2DM patients with chronic stable angina.
- patients with glycated hemoglobin (HbA1c) levels of 6.0-10.0%.
- patients aged 20-80 years.
- patients with a body mass index of ≥ 22 kg/m2.
- patients who provided written informed consent.
Key exclusion criteria (10 listed)
- patients with type 1 diabetes mellitus or secondary diabetes mellitus.
- patients with renal dysfunction (estimated glomerular filtration rate < 45 mL/min/1.73 m2).
- patients with left ventricular ejection fraction (LVEF) < 30%.
- patients with untreated cancer.
- patients with hepatic cirrhosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10 MGAlso: Empaeligible subjects were randomly and equally assigned to the empagliflozin add-on group (empagliflozin 10 mg/ day). | Drug | Empagliflozin |
| Vildagliptin 50 MGAlso: Vildaeligible subjects were randomly and equally assigned to vildagliptin add-on group (vildagliptin 50 mg/day as the initial dose). | Drug | Vildagliptin |
Primary outcome
LVEF %
Time frame: 6 months
echocardiographic measurements
Sortilin (ng/ml)
Time frame: 6 months
Serum Biomarkers
LDL (mg/dl)
Time frame: 6 months
Lipid profile
3 secondary outcomes
hsCRP (mg/L)
Time frame: 6 months
HbA1c %
Time frame: 6 months
FBG (mg/dl)
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 28403850Tanaka A, Shimabukuro M, Okada Y, Taguchi I, Yamaoka-Tojo M, Tomiyama H, Teragawa H, Sugiyama S, Yoshida H, Sato Y, Kawaguchi A, Ikehara Y, Machii N, Maruhashi T, Shima KR, Takamura T, Matsuzawa Y, Kimura K, Sakuma M, Oyama JI, Inoue T, Higashi Y, Ueda S, Node K; EMBLEM Trial Investigators. Rationale and design of a multicenter placebo-controlled double-blind randomized trial to evaluate the effect of empagliflozin on endothelial function: the EMBLEM trial. Cardiovasc Diabetol. 2017 Apr 12;16(1):48. doi: 10.1186/s12933-017-0532-8.
- Background: PubMed 32977831Shimizu W, Kubota Y, Hoshika Y, Mozawa K, Tara S, Tokita Y, Yodogawa K, Iwasaki YK, Yamamoto T, Takano H, Tsukada Y, Asai K, Miyamoto M, Miyauchi Y, Kodani E, Ishikawa M, Maruyama M, Ogano M, Tanabe J; EMBODY trial investigators. Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trial. Cardiovasc Diabetol. 2020 Sep 25;19(1):148. doi: 10.1186/s12933-020-01127-z.
- Background: PubMed 27210264Schernthaner G, Schernthaner-Reiter MH, Schernthaner GH. EMPA-REG and Other Cardiovascular Outcome Trials of Glucose-lowering Agents: Implications for Future Treatment Strategies in Type 2 Diabetes Mellitus. Clin Ther. 2016 Jun;38(6):1288-1298. doi: 10.1016/j.clinthera.2016.04.037. Epub 2016 May 19.
- Background: PubMed 27701934Naing S, Poliyedath A, Khandelwal S, Sigala T. Impact of EMPA-REG OUTCOME(R) on the management of type 2 diabetes mellitus: a review for primary care physicians. Postgrad Med. 2016 Nov;128(8):822-827. doi: 10.1080/00325481.2016.1245093. Epub 2016 Oct 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lamiaa Khedr, Prof. study director
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empagliflozin 10 MG and Vildagliptin 50 MG in people with Coronary Artery Disease and Type 2 Diabetes, run by Damanhour University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LVEF % (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06313008, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.